製藥工廠基本資料Site Master File
(SMF)製備說明
 
EXPLANATORY NOTES FOR PHARMACEUTICAL

MANUFACTURERS ON THE PREPARATION OF A

SITE MASTER FILE 

PE008-4 1 Annex (1 January 2011)

 
 

行政院衛生署 
中華民國 100 年 4 月 

  1/11
 序 

為強化藥物製造業者之管理，並與國際規範接軌，本署參考國際作法，
規定製藥工廠應製備「工廠基本資料Site Master File (SMF) 」（以下簡稱
，供本署執行各項檢查作業前，瞭解製藥工廠之最新概況，以作有效
SMF）
之規劃與安排。本署前藥物食品檢驗局曾於91年6月10日以藥檢科字第
9109647號函公布製備「工廠基本資料Site Master File (SMF) 」之說明備忘
錄。該備忘錄係參照1993年PIC/S組織公布之「EXPLANATORY NOTES FOR
PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A
SITE MASTER FILE」翻譯而成。該組織於2011年1月1日公布新版之SMF，
主要新增有關品質風險評估政策之相關要求，本次係參照該版本修正SMF
製備說明內容。

SMF 內容應包含廠內各項資料，但盡可能不超過 25 到 30 頁（附錄另

加）
，並以簡要計畫、大綱圖示或圖解編排方式，取代使用敘述的方式，另
其附件若使用 A4 紙張列印時，亦應清楚可讀。此外，工廠基本資料應列屬
於廠內品質管理系統文件的一部份，該份文件應有版本編號、審核日期及
生效日期，並應定期進行審閱以確保該文件為最新版本。

SMF 應包含廠內之品質管理策略及各項作業等之特定資訊，若廠內僅
執行部分之藥品生產作業，例如：僅有包裝作業時，則僅需描述該作業。
另，本說明內容適用於所有類型之製造作業，例如：藥品之生產、包裝、
貼標、檢驗、重貼標及重包裝等。

本說明內容以中英文對照方式呈現，製藥工廠應依該新版格式製備廠
內之 SMF。未來，PIC/S 組織若有更新時，本署亦將配合隨時更新並公布
週知。

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 工廠基本資料內容 (CONTENT OF SITE MASTER FILE)
1. 製造廠基本資料
(GENERAL INFORMATION ON THE MANUFACTURER)
1.1 製造廠聯絡資料
- 製造廠名稱及正式地址；
- 工廠名稱及地址，廠區內各建築與生產
單位之位置；
- 當有產品瑕疵或回收時，製造廠的聯絡
資訊，包括聯絡人員 24 小時的聯絡電
話；
- 工廠之識別碼，如 GPS (全球定位系統)
資訊或任何其他地理定位系統。
- 工廠登記字號。
1.2 工廠經核准之藥品製造作業
- 附件 1 附上主管機關核發且仍在效期
內之製造許可影本。若主管機關未核發
製造許可時，亦應註明；
- 簡述未納入製造許可但由相關主管機
關 (包括國外機關) 核准之各種劑型/
作業的製造、輸入、輸出、運銷及其他
項目；
- 列述不包含在附件 1 由該廠製造的產
品類型 (列舉於附件 2)；
- 列舉工廠最近 5 年內接受 GMP 稽查之
清單，包括日期及執行稽查之主管機關
 
1.1 Contact information on the manufacturer
- Name and official address of the
manufacturer;
- Names and street addresses of the site,
buildings and production units located on
the site;
- Contact information of the manufacturer
including 24 hrs telephone number of
the contact personnel in the case of
product defects or recalls;
- Identification number of the site as e.g.
GPS details or any other geographic
location system.
- Certification number of the site.
1.2 Authorised pharmaceutical
manufacturing activities of the site
- Copy of the valid manufacturing
authorisation issued by the relevant
Competent Authority in Appendix 1. If
the Competent Authority does not issue
manufacturing authorisations, this
should be stated;
- Brief description of manufacture,
import, export, distribution and other
activities as authorised by the relevant
Competent Authorities including foreign
authorities with authorised dosage
forms/activities, respectively; where not
covered by the manufacturing
authorisation;
- Type of products currently manufactured
on-site (list in Appendix 2) where not
covered by Appendix 1;
- List of GMP inspections of the site
within the last 5 years; including dates
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 名稱/國家。將現行 GMP 證明書影本置 and name/country of the Competent
於附件 3。 Authority having performed the
inspection. A copy of current GMP
certificate (Appendix 3) should be
included, if available.
1.3 廠內其他之製造作業 1.3 Any other manufacturing activities
carried out on the site
- 描述廠內任何非藥品之作業。 - Description of non-pharmaceutical
activities on-site, if any.
2. 製造廠之品質管理系統
(QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER)
2.1 製造廠之品質管理系統 2.1 The quality management system of the
manufacturer
- 簡述公司內運作之品質管理系統及其 - Brief description of the quality
所參照之標準； management systems run by the
company and reference to the standards
used;
- 有關維持品質系統之相關職責說明，包 - Responsibilities related to the
括高層管理者之職責； maintaining of quality system including
senior management;
- 廠內被認可及認證作業之資訊，包括認 - Information of activities for which the
證的日期及內容，以及認證機構名稱。 site is accredited and certified, including
dates and contents of accreditations,
names of accrediting bodies.
2.2 最終產品之放行程序 2.2 Release procedure of finished products
- 詳述負責批次核定與放行程序之被授 - Detailed description of qualification
權人員/合格人員之資格要求 (教育背 requirements (education and work
景與工作經驗)； experience) of the Authorised Person(s) /
Qualified Person(s) responsible for batch
certification and releasing procedures;
- 敘述批次核定與放行程序； - General description of batch certification
and releasing procedure;
- 在最終產品待驗與放行，以及評估是否 - Role of Authorised Person / Qualified
符合上市許可中，被授權人員/合格人員 Person in quarantine and release of
所擔任之角色； finished products and in assessment of
compliance with the Marketing
Authorisation;
- 若廠內有多位被授權人員/合格人員 - The arrangements between Authorised

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 時，他們的職責區分；
- 敘明管制策略是否採用製程分析技術
(PAT) 及/或即時放行或參數放行。
2.3 供應商及合約商之管理 2.3 Management of suppliers and
contractors
- 簡要彙整供應鏈體系之建立/資訊，以
及外部稽核計畫；
- 簡述合約商、原料藥 (API) 製造業者
與其他關鍵性原物料供應商之資格認
可系統；
- 為確保所製造之產品符合 TSE (傳染性
動物海綿狀腦病) 指引所採取之措施；
- 用以發覺或辨識產品、半製品 (如尚未
包裝之錠劑)、原料藥或賦型劑等被仿
冒/造假的措施；
- 相關的製造與檢驗使用廠外科學、分析
或其他技術支援；
- 列出委託製造業者與實驗室清單，包括
其地址與委託資訊，亦包括委外製造與
品質管制作業供應鏈的流程圖，例如：
無菌製備所使用之直接包裝材料的滅
菌、起始原料之檢驗等，將上述資料呈
現於附件4；
- 簡述委託者與受託者間在符合上市許
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Persons / Qualified Persons when several
Authorised Persons / Qualified Persons
are involved;
- Statement on whether the control
strategy employs Process Analytical
Technology (PAT) and/or Real Time
Release or Parametric Release.
- A brief summary of the
establishment/knowledge of supply
chain and the external audit program;
- Brief description of the qualification
system of contractors, manufacturers of
active pharmaceutical ingredients (API)
and other critical materials suppliers;
- Measures taken to ensure that products
manufactured are compliant with TSE
(Transmitting animal spongiform
encephalopathy) guidelines;
- Measures adopted where
counterfeit/falsified products, bulk
products (i.e. unpacked tablets), active
pharmaceutical ingredients or excipients
are suspected or identified;
- Use of outside scientific, analytical or
other technical assistance in relation to
manufacture and analysis;
- List of contract manufacturers and
laboratories including the addresses and
contact information and flow charts of
supply-chains for outsourced
manufacturing and Quality Control
activities; e.g. sterilisation of primary
packaging material for aseptic processes,
testing of starting raw materials etc,
should be presented in Appendix 4;
- Brief overview of the responsibility
 可所各自分擔的責任 (對於未納入在 sharing between the contract giver and
2.2 中的部份)。 acceptor with respect to compliance with
the Marketing Authorisation (where not
included under 2.2).
2.4 品質風險管理 2.4 Quality Risk Management (QRM)
- 簡述製造業者所使用的品質風險管理 - Brief description of QRM methodologies
方法； used by the manufacturer;
- 品質風險管理之範圍與重點，包括簡述 - Scope and focus of QRM including brief
在母公司階層所實施以及在各子公司 description of any activities which are
所實施的任何作業。應提及品質風險管 performed at corporate level, and those
理系統的任何應用，以評估供應品的一 which are performed locally. Any
致性。 application of the QRM system to assess
continuity of supply should be
mentioned.
2.5 產品品質檢討 2.5 Product Quality Reviews
- 簡述所使用的方法。 - Brief description of methodologies used.
3. 人事 (PERSONNEL)
- 將標明品質管理、生產、品質管制之職 - Organisation chart showing the
位/職稱的組織圖置於附件5，包括高階 arrangements for quality management,
管理者與被授權人員/合格人員； production and quality control
positions/titles in Appendix 5, including
senior management and Authorised
Person(s) / Qualified Person(s);
- 分別從事品質管理、生產、品質管制、 - Number of employees engaged in the
倉儲及運銷的員工人數。 quality management, production, quality
control, storage and distribution
respectively.
4. 廠房設施及設備 (PREMISES AND EQUIPMENT)
4.1 廠房設施 4.1 Premises
- 簡述工廠，包括廠區之面積及各棟建築 - Short description of plant; size of the site
物清單。若生產作業係針對不同市場需 and list of buildings. If the production
求而在廠區內不同建築物執行時，例如 for different markets, i.e. for local, EU,
針對國內、歐盟、美國等，則應列出各 USA, etc. takes place in different
棟建築物之標的市場 (若在 1.1 項沒有 buildings on the site, the buildings
加以區分時)； should be listed with destined markets
identified (if not identified under 1.1);
- 簡圖或附有比例尺之製造區域的描述 - Simple plan or description of
(不需建築圖或工程圖)； manufacturing areas with indication of

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 scale (architectural or engineering
drawings are not required);
- 生產區域之配置及流程圖 (見附件 6) - Lay outs and flow charts of the
顯示各房間的潔淨度分級與鄰近區域 production areas (in Appendix 6)
的壓差，並標示房間內之作業項目(例 showing the room classification and
如調製、充填、儲存、包裝等)； pressure differentials between adjoining
areas and indicating the production
activities (i.e. compounding, filling,
storage, packaging, etc.) in the rooms;
- 倉庫與儲存區域之配置，如有高毒性、 - Lay-outs of warehouses and storage
危害性及致敏性之原物料時，應標示其 areas, with special areas for the storage
儲存與處理的特定區域； and handling of highly toxic, hazardous
and sensitizing materials indicated, if
applicable;
- 若未在前述平面圖上標示時，則應簡述 - Brief description of specific storage
其特定的儲存條件。 conditions if applicable, but not
indicated on the lay-outs.
4.1.1 簡述空調 (HVAC) 系統 4.1.1 Brief description of heating,
ventilation and air conditioning
(HVAC) systems
- 簡述空氣供應、溫度、濕度、壓差、換 - Principles for defining the air supply,
氣數及空氣再循環率 (%) 策略之訂定 temperature, humidity, pressure
原則。 differentials and air change rates, policy
of air recirculation (%).
4.1.2 簡述水系統 4.1.2 Brief description of water systems
- 產製用水的品質參考依據。 - Quality references of water produced;
- 附件 7 附上水系統之圖示。 - Schematic drawings of the systems in
Appendix 7.
4.1.3 簡述其他相關公用設施，例如蒸汽、 4.1.3. Brief description of other relevant
壓縮空氣、氮氣等。 utilities, such as steam, compressed
air, N2, etc.
4.2 設備 4.2 Equipment
4.2.1 附件 8 提供主要生產與品管實驗室 4.2.1 Listing of major production and
設備之清單，並標示出設備的關鍵 control laboratory equipment with
性部分 critical pieces of equipment identified
should be provided in Appendix 8
4.2.2 清潔與衛生 4.2.2 Cleaning and sanitation
- 簡述與產品有接觸的設備表面之清潔 - Brief description of cleaning and

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 與衛生處理方法 (例如，手工清潔、自
動就地清潔等)。
4.2.3 GMP 相關之電腦化系統
- 描述與 GMP 有重要相關之電腦化系統
(設備上特定性之可程式邏輯控制器
(PLCs) 除外)。
5. 文件 (DOCUMENTATION)
- 描述文件系統 (例如，電子文件、紙本
文件)；
- 當文件及紀錄 (包括合適時藥物安全
監視數據) 係儲存或歸檔於廠外時：列
出該文件/紀錄之類型、儲存地點之名稱
與地址，以及估計從廠外取回文件所需
之時間。
6. 生產 (PRODUCTION)
6.1 產品之類型 (可參考附件 1 與附件 2)： 6.1. Type of products (references to
Appendix 1 or 2 can be made):
- 所製造產品之類型，包括； - Type of products manufactured
* 廠內製造之人用及動物用藥品劑型之
清單；
* 廠內為任何臨床試驗所製造的研究用
藥品 (IMP) 之劑型清單，當其製造場
所與人員及上市產品之製造場所與人
員不同時，則應有這些場所與人員的資
訊；
- 具有毒性或危害性物質之處理方法
(例如，具高藥理活性及/或具致敏性之
特性者)；
- 若以專用設施或以時段切換生產為基
礎的方式所製造之產品類型，則應予以
sanitation methods of product contact
surfaces (i.e. manual cleaning, automatic
Clean-in-Place, etc).
4.2.3 GMP critical computerised systems
- Description of GMP critical
computerised systems (excluding
equipment specific Programmable
Logic Controllers (PLCs).
- Description of documentation system
(i.e. electronic, manual);
- When documents and records are stored
or archived off-site (including
pharmacovigilance data, when
applicable): List of types of
documents/records; Name and address of
storage site and an estimate of time
required retrieving documents from the
off-site archive.
including;
* list of dosage forms of both human and
veterinary products which are
manufactured on the site;
* list of dosage forms of investigational
medicinal products (IMP) manufactured
for any clinical trials on the site, and
when different from the commercial
manufacturing, information of
production areas and personnel;
- Toxic or hazardous substances handled
(e.g. with high pharmacological activity
and/or with sensitising properties);
- Product types manufactured in a
dedicated facility or on a campaign

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 敘明；
- 若採用製程分析技術 (PAT)：則概述其
相關技術及所連結之電腦化系統。
6.2 製程確效
- 簡述製程確效之一般策略；
- 重處理或再加工之策略。
6.3 原物料管理及倉儲
- 原料、包裝材料、待分包裝產品及最終
產品處理的安排，包括抽樣、待驗、放
行及儲存；
- 拒用原物料及產品處理的安排。
7. 品質管制 (QUALITY CONTROL)
- 描述廠內在物理、化學、微生物學及生
物學試驗方面所執行的品質管制作業。
8. 運銷、申訴、產品瑕疵及回收
(DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS)
8.1 運銷(針對製造業者所負的責任)
- 產品出貨的對象 (持有批發商許可
者，持有製造許可者等) 及其地點 (歐
盟/歐洲經濟區、美國等)；
- 所使用系統的描述，以確認每一客戶/
接收者係合法取得該製造業者所製造
的藥品；
- 簡述在運送期間確保在適當環境條件
下的系統，例如，溫度監控/管控；
 
basis, if applicable;
- Process Analytical Technology (PAT)
applications, if applicable: general
statement of the relevant technology, and
associated computerized systems.
6.2 Process validation
- Brief description of general policy for
process validation;
- Policy for reprocessing or reworking.
6.3 Material management and warehousing
- Arrangements for the handling of
starting materials, packaging materials,
bulk and finished products including
sampling, quarantine, release and
storage;
- Arrangements for the handling of
rejected materials and products.
- Description of the Quality Control
activities carried out on the site in terms
of physical, chemical, and
microbiological and biological testing.
8.1 Distribution (to the part under the
responsibility of the manufacturer)
- Types (wholesale licence holders,
manufacturing licence holders, etc) and
locations (EU/EEA, USA, etc.) of the
companies to which the products are
shipped from the site;
- Description of the system used to verify
that each customer / recipient is legally
entitled to receive medicinal products
from the manufacturer;
- Brief description of the system to
ensure appropriate environmental
conditions during transit, e.g. temperature
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 monitoring/ control;
- 產品運銷的安排及維持產品可被追溯 - Arrangements for product distribution
的方法； and methods by which product
traceability is maintained;
- 防止製造業者之產品淪為非法供應鏈 - Measures taken to prevent
所採取的措施。 manufacturers’ products to fall in the
illegal supply chain.
8.2 申訴，產品瑕疵及回收 8.2 Complaints, product defects and
recalls
- 簡述處理申訴、產品瑕疵及回收的系 - Brief description of the system for
統。 handling complains, product defects and
recalls.
9. 自我查核 (SELF INSPECTIONS)
- 簡述自我查核系統，並將重點放在訂定 - Short description of the self inspection
查核計畫時查核範圍的選擇標準、實務 system with focus on criteria used for
安排及後續跟催行動。 selection of the areas to be covered
during planned inspections, practical
arrangements and follow-up activities.

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附件
附件 1 效期內的製造許可影本。 Appendix 1 Copy of valid manufacturing
authorization.
附件2 製造劑型之清單，包括所用原料藥 Appendix 2 List of dosage forms
之INN-名稱或一般名稱 (可行 manufactured including the INN-names or
時)。 common name (as available) of active
pharmaceutical ingredients (API) used.
附件 3 效期內的 GMP 證明書影本。 Appendix 3 Copy of valid GMP
Certificate.
附件 4 委 (受) 託製造業者與實驗室之清 Appendix 4 List of contract manufacturers
單，包括其住址、聯絡方式，以及 and laboratories including the addresses and
這些委(受) 託作業供應鏈之流程 contact information, and flow-charts of the
圖。 supply chains for these outsourced
activities.
附件 5 組織圖 Appendix 5 Organisational charts.
附件 6 生產區配置圖，包括物流及人流， Appendix 6 Lay outs of production areas
每一產品類型 (劑型) 的製造作 including material and personnel flows,
業流程圖。 general flow charts of manufacturing
processes of each product type (dosage
form).
附件 7 水系統圖示。 Appendix 7 Schematic drawings of water
systems.
附件 8 主要的生產及實驗室設備清單。 Appendix 8 List of major production and
laboratory equipment.
 

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